# China NMPA Product Recall - Defibrillator/Monitoring System LIFEPAK 15

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/81ee10a0-25e3-48af-9f76-bbbdbdbf58fa/
Source feed: China

> China NMPA product recall for Defibrillator/Monitoring System LIFEPAK 15 by Physio-Control, Inc. published November 29, 2016. Recall level: Level 3 Recall. Physio-Control, Inc. initiated a Class III voluntary recall for its LIFEPAK 15 defibrillator/monitor

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Physio-Control, Inc. Active recall of defibrillation/monitoring systems
- Company Name: Physio-Control, Inc.
- Publication Date: 2016-11-29
- Product Name: Defibrillator/Monitoring System LIFEPAK 15
- Recall Level: Level 3 Recall
- Recall Reason: When using kPa or % settings for EtCO2 and readings exceeding 9.9, the LIFEPAK 15 respiratory rate display may partially obscure the first digit of the EtCO2 value. If the EtCO2 value is actually high but clinically interpreted as low, it could lead to incorrect treatment. There are currently no reports of patients being mistreated or harmed due to this issue.
- Discovering Company: Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd.
- Manufacturing Company: Physio-Control, Inc.
- Summary: Physio-Control, Inc. initiated a Class III voluntary recall for its LIFEPAK 15 defibrillator/monitoring system, as reported by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd. to the National Medical Products Administration (NMPA) in October 2016, with publication on November 29, 2016. The recall stems from a potential display anomaly where, when using kPa or % settings for End-Tidal Carbon Dioxide (EtCO2) and the reading surpasses 9.9, the device may partially obscure the first digit of the EtCO2 value. This issue could lead to a critical misinterpretation of a high EtCO2 value as low, potentially resulting in inappropriate patient treatment. The recall affects 105 units imported to China, as part of a global action, though no adverse patient events have been reported due to this specific issue. To mitigate risk, Physio-Control instructed distributors and users to disseminate this information broadly. Users are advised to closely monitor EtCO2 waveforms, observe the full displayed range, activate EtCO2 alarms, and consider switching the unit setting to mmHg. Physio-Control also committed to releasing a software update on its official website, with user notifications, to permanently resolve the display anomaly.

Company: https://www.globalkeysolutions.net/companies/physio-control-inc/c025f05e-3b2b-4081-a12e-0e310448bbe6/